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Course… … .. B. Pharm Sem… … … .. 5th Year… … … … 3 Subject name… … Industrial Pharmacy Code… … … .. BP - 502 T Topic… … …. .. Tablets Tablets They are the pharmaceutical oral solid dosage form . They are fornulated either by molding and compression. They vary in shape, size and weight depending on the medicinal substances . Advantages 1.Least content variability 2.Light and compact 3.Easy and cheap to package 4.Easy to carry 5.Sustained release product is possible by various techniques. 6.Suitable for large scale production. 7.Product identification is easy. Disadvantages 1.Difficult to swallow in case of children and unconcious patient. 2.Drugs with poor wetting , slow dissolution properties may be difficult to formulate . 3.Bitter tasting drugs , drugs with an obejctionable odour may require coating or encapsulation. Classification of tablets 1. Orally ingested tablets ● compressed tablets e.g Paracetamol ● Multi compressed tablets ● Delayed release tablets e.g Enteric coated tablets ● Sugar coated tablets e.g Multivitamin tablets ● Film coated tablets e.g Metronidazole tablets ● Chewable tablets e.g Antacid tablets 2. Used in oral cavity ● Buccal tablet e.g Vitamin C tablet ● Sublingual tablet e. g Vicks Menthol tablet ● Troches or lozenges ● Dental cone 3. Other route ● Implantation tablet ● Suppositories or insert e.g Clotrimazole tablet 4.Used to prepare solution ● Effervescent tablet e .g Disprin ● Dispensing tablet e.g Enzyme tablet(Digiplex) ● Hypodermic tablet Excipients An excipient is a substance formulated alongside the active ingredient of a medication, included for the purpose of long-term stabilization, bulking up solid formulations that contain potent active ingredients in small amounts (thus often referred to as "bulking agents", "fillers", or "diluents"), or to confer a therapeutic enhancement on the active ingredient in the final dosage form, such as facilitating drug absorption, reducing viscosity, or enhancing solubility. Excipients can also be useful in the manufacturing process, to aid in the handling of the active substance concerns such as by facilitating powder flowability or non-stick properties, in addition to aiding in vitro stability such as prevention of denaturation or aggregation over the expected shelf life. The selection of appropriate excipients also depends upon the route of administration and the dosage form, as well as the active ingredient and other factors. A comprehensive classification system based on structure-property-application relationships has been proposed for excipients used in parenteral medications. Types Antiadherents Antiadherents reduce the adhesion between the powder (granules) and the punch faces and thus prevent sticking to tablet punches by offering a non-stick surface. They are also used to help protect tablets from sticking. The most commonly used is magnesium stearate. Binders Binders hold the ingredients in a tablet together. Binders ensure that tablets and granules can be formed with required mechanical strength, and give volume to low active dose tablets. Binders are usually: Saccharides and their derivatives: Disaccharides: sucrose, lactose; Polysaccharides and their derivatives: starches, cellulose or modified cellulose such as microcrystalline cellulose and cellulose ethers such as hydroxypropyl cellulose (HPC); Sugar alcohols such as xylitol, sorbitol or mannitol; Protein: gelatin; Synthetic polymers: polyvinylpyrrolidone (PVP), polyethylene glycol (PEG)... Binders are classified according to their application: Solution binders are dissolved in a solvent (for example water or alcohol can be used in wet granulation processes). Examples include gelatin, cellulose, cellulose derivatives, polyvinylpyrrolidone, starch, sucrose and polyethylene glycol. Dry binders are added to the powder blend, either after a wet granulation step, or as part of a direct powder compression (DC) formula. Examples include cellulose, methyl cellulose, polyvinylpyrrolidone and polyethylene glycol. Coatings Tablet coatings protect tablet ingredients from deterioration by moisture in the air and make large or unpleasant-tasting tablets easier to swallow. For most coated tablets, a cellulose ether hydroxypropyl methylcellulose (HPMC) film coating is used which is free of sugar and potential allergens. Occasionally, other coating materials are used, for example synthetic polymers, shellac, corn protein zein or other polysaccharides. Capsules are coated with gelatin. Enterics control the rate of drug release and determine where the drug will be released in the digestive tract. Materials used for enteric coatings include fatty acids, waxes, shellac, plastics, and plant fibers. Colors Colors are added to improve the appearance of a formulation. Color consistency is important as it allows easy identification of a medication. Furthermore, colors often improve the aesthetic look and feel of medications. Small amounts of coloring agents are easily processed by the body, although rare reactions are known, notably to tartrazine.Commonly, titanium oxide is used as a coloring agent to produce the popular opaque colors along with azo dyes for other colors. By increasing these organoleptic properties a patient is more likely to adhere to their schedule and therapeutic objectives will also have a better outcome for the patient especially children. Disintegrants Disintegrants expand and dissolve when wet causing the tablet to break apart in the digestive tract, or in specific segments of the digestion process, releasing the active ingredients for absorption. They ensure that when the tablet is in contact with water, it rapidly breaks down into smaller fragments, facilitating dissolution. Examples of disintegrants include: Crosslinked polymers: crosslinked polyvinylpyrrolidone (crospovidone), crosslinked sodium carboxymethyl cellulose (croscarmellose sodium). The modified starch sodium starch glycolate. Flavors can be used to mask unpleasant tasting active ingredients and improve the acceptance that the patient will complete a course of medication. Flavorings may be natural (e.g. fruit extract) or artificial. For example, to improve: a bitter product - mint, cherry or anise may be used a salty product - peach, apricot or liquorice may be used a sour product - raspberry or liquorice may be used an excessively sweet product - vanilla may be used Glidants Glidants are used to promote powder flow by reducing interparticle friction and cohesion. These are used in combination with lubricants as they have no ability to reduce wall friction. Examples include silica gel, fumed silica, talc, and magnesium carbonate. However, some silica gel Glidants such as Syloid(R) 244 FP and Syloid(R) XDP are multi-functional and offer several other performance benefits in addition to reducing interparticle friction including moisture resistance, taste marketing etc. Lubricants Lubricants prevent ingredients from clumping together and from sticking to the tablet punches or capsule filling machine. Lubricants also ensure that tablet formation and ejection can occur with low friction between the solid and die wall. Common minerals like talc or silica, and fats, e.g. vegetable stearin, magnesium stearate or stearic acid are the most frequently used lubricants in tablets or hard gelatin capsules. Lubricants are agents added in small quantities to tablet and capsule formulations to improve certain processing characteristics. While lubricants are often added to improve manufacturability of the drug products, it may also negatively impact the product quality.
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